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Senior Quality Consultant
Medtech Services
Confirmed live in the last 24 hours
Locations
Philadelphia, PA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Sales
Requirements
  • 8 + years of relevant work experience within Life Sciences, Healthcare, or other regulated industries (ex. Consumer Goods, Chemical, Cosmetics)
  • Experience implementing, designing solutions, and supporting software applications
  • Self-starter and motivated individual with the proven ability to work independently in a dynamic environment
  • Intermediate knowledge of Quality related processes (e.g. CAPA, Complaints, Non-Conformance, Product Surveillance, Change Management)
  • Understanding of compliance and computer systems validation requirements
  • Proven ability to manage diverse customers and /or stakeholders and ability to communicate at multiple levels of the organization
  • Ability to quickly understand customer requirements and create corresponding solution designs
  • Knowledge of SaaS/Cloud software solutions
  • Bachelor's degree or equivalent work experience required
Responsibilities
  • Lead Veeva Vault Quality implementations and handle project management responsibilities, such as resource planning, project risk management, leading cross-functional teams, and budget tracking & forecasting of the engagement
  • Conduct Vault Design Review and Configuration workshops with MedTech stakeholders from Business and IT: gather requirements, design & prototype, configure and support the validation of the delivered Quality processes
  • Work closely with customers' business and IT stakeholders and develop scalable solutions that meet Quality regulatory compliance and customer requirements
  • Mentor project team members and junior consultants
  • Continue to develop industry knowledge and enhancements the delivery model to meet the changing business needs of Veeva and our customers
  • Provide insight and recommendations to improve our technology and work closely with our Product team to ensure the best solutions for our customers
Desired Qualifications
  • Work experience in Medical Devices and/or Diagnostics space
  • Computer Science, Life Science, or related degree preferred
  • Strong knowledge of MedTech industry standards and regulatory requirements (e.g.: FDA QSR, ISO 13485, 21 CFR Part 11, 21 CFR 820, 210, GAMP)
  • Direct experience with regulated systems or data-driven applications such as Veeva Vault solutions, NextDocs, Documentum, FirstDoc/FirstPoint, Trackwise, Medidata, Liquent Insight
  • Experience with PLM and LIMs systems such as Arena, TeamCenter, Propel, Agilent, Labworks
  • SaaS/Cloud delivery experience
  • Experience in Services Delivery Management or Pre-Sales presentations and demonstrations
Veeva Systems

1,001-5,000 employees

Cloud computing services for pharmaceutical companies.
Company Overview
Veep's mission is to help R&D, quality, and regulatory teams eliminate inefficiencies and bring high-quality, safe, sustainable products to market without compromising quality. The company builds cloud-based tools for pharmaceutical research.
Benefits
  • Parental leave
  • PTO
  • Free food
  • Health, dental, & vision insurance
  • Gym membership reimbursement
Company Core Values
  • Do the Right Thing
  • Customer Success
  • Employee Success
  • Speed